May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

This funding opportunity announcement (FOA) encourages the
submission of research project grant applications from institutions/organizations
that propose to: (1) improve the measurement of racial/ethnic discrimination
in health care delivery systems through improved instrumentation, data
collection, and statistical/analytical techniques; (2) to enhance
understanding of the influence of racial/ethnic discrimination in health care
delivery and its association with disparities in disease incidence,
treatment, and outcomes among disadvantaged racial/ethnic minority groups:
and (3) to reduce the prevalence of racial/ethnic health disparities through
the development of interventions to reduce the influence of racial/ethnic
discrimination on health care delivery systems in the United States (U.S.).

Key Dates

Posted Date

March
17, 2011

Open Date (Earliest Submission Date)

May 16, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

It is critical that applicants follow the instructions in
the SF
424 (R&R) Application Guide except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

This funding opportunity announcement (FOA) encourages the
submission of research project grant applications from institutions/organizations
that propose to: (1) improve the measurement of racial/ethnic discrimination in
health care delivery systems through improved instrumentation, data collection,
and statistical/analytical techniques; (2) to enhance understanding of the
influence of racial/ethnic discrimination in health care delivery and its
association with disparities in disease incidence, treatment, and outcomes
among disadvantaged racial/ethnic minority groups: and (3) to reduce the prevalence
of racial/ethnic health disparities through the development of interventions to
reduce the influence of racial/ethnic discrimination on health care delivery
systems in the United States (U.S.).

BACKGROUND

Racial/ethnic minorities
suffer disproportionate morbidity and mortality from chronic diseases such as
cancer, heart disease, diabetes and stroke. Although racial/ethnic differences
in morbidity and mortality can be partially explained by differences in
lifestyle, health behavior and financial access to care, these factors do not
entirely explain differences in incidence, treatment or outcomes. The
Institute of Medicine (IOM) report on unequal treatment (http://www.nap.edu/openbook.php?isbn=030908265X)
as well as several other reviews show that
racial/ethnic minorities also less frequently receive appropriate care which
has an adverse impact on their health outcomes including higher recurrence
rates, poorer survival experiences and higher morbidity and mortality. An
association between perceived discrimination and poorer health status has also
been found. The IOM report concluded in part that “(1) Racial/ethnic
disparities in healthcare occur in the context of broader historic and
contemporary social and economic inequality and evidence of persistent racial
and ethnic discrimination in many sectors of American life; (2) health systems,
healthcare providers, patients and utilization managers may contribute to
racial and ethnic disparities in healthcare; and (3) that health provider bias,
stereotyping, prejudice and clinical uncertainty may contribute to racial and
ethnic disparities in health care.” The Trans-US Department of Health and
Human Services Health Disparities Progress Review Group also recognized the
need to discuss the impact of racism as a fundamental cause of health
disparities.

The IOM committee
recommended that additional research be conducted to provide insight into how
and why racial/ethnic disparities occur and to test interventions and
strategies to eliminate them, including research that provides further
elucidation on: (1) patient, provider and institutional contributions to
healthcare disparities; (2) the relative contributions of provider bias,
stereotyping, prejudice, and uncertainty to racial/ethnic disparities in
diagnosis, treatment, and outcomes of care; and (3) the role of non-physician
healthcare professionals, pharmacists, allied health professional and
non-professional staff contribution to healthcare disparities.

The National Research
Council (http://www.nap.edu/catalog.php?record_id=10887)
defined racial discrimination as the “(1)
differential treatment on the basis of race that disadvantages a racial group
and, (2) treatment on the basis of inadequately justified factors that
disadvantages a racial group. For the purposes of this program announcement
race is defined as a continuously evolving social construct used to categorize
individuals into groups that have typically been based on the physical
characteristics (e.g. skin color, hair texture or other distinctive
characteristics, etc.) of an individual or their ancestors. Ethnicity refers
to cultural groups that have been typically defined by a common language,
religion, nationality or heritage. This program announcement focuses on
examining overt as well as subtle racial/ethnic discriminatory behavior and
processes perceived or experienced by historically disadvantaged racial/ethnic minority
groups and their contribution to persistent disparities in the receipt of
quality health care and disease outcomes that have been observed among these
populations.

Racial/ethnic bias is
hypothesized to contribute to disparities in health through five key pathways.
These include increased exposure and susceptibility to (1) economic and social
deprivation; (2) toxic substances and hazardous conditions; (3) socially
inflicted mental and physical trauma directly experienced or witnessed; (4)
targeted marketing of potentially harmful commodities such as tobacco, alcohol
and illicit drugs; and (5) inadequate or degrading medical care.

The influence of
non-clinical characteristics, either actual or perceived, on provider
perception of racial/ethnic minority patients might also have an impact on the
health care received by patients. Physician recommendations and referrals have
been shown to contribute to racial disparities in referrals for kidney
transplantation and receipt of some cardiovascular procedures. Several
mechanisms through which providers potentially contribute to racial/ethnic
disparities in health have been suggested. These include provider bias against
racial/ethnic minorities, uncertainty in their interactions with minority
patients, beliefs or stereotypes regarding the health behavior of minority
patients and patient response to perceived provider mistreatment or other
negative racial experiences. In one report, 63% of the 76 participants in a
cross-sectional survey indicated that they had experienced discrimination in
their interactions with their health care provider because of their race or
color. Similarly, 29% of African Americans and more than 10% of
Latino/Hispanic, Filipino, and Korean respondents in the King County [Seattle, Washington]
Health and Ethnicity Survey of 1995-1996 reported that they had experienced
discrimination when seeking or obtaining health care due to their race or
ethnicity. In interviews conducted among African Americans after the survey,
perceived discriminatory experiences reported by participants included
differential treatment, negative attitudes, being treated as if they were
unintelligent, being ignored, inappropriate allegations and racist remarks.
This highlights the importance of culturally competent relationships between
patients and providers which have been defined as collaborative partnerships
that facilitate successful and satisfactory delivery of care.

Experiences with
racial/ethnic discrimination in the healthcare setting are not limited to
patients. In a recent national cross-sectional survey, October 2006-February
2007, 60% of African-American; 33% of Asian; 17% of Hispanic/Latino(a) 42% of
other race and 30% of Non-Hispanic white physicians reported the perception
that patients refused their care because of their race/ethnicity. There is
little empirical research however; that directly examines how patient biases
towards providers affect receipt of appropriate health care.

Negative experiences in the
health care setting may profoundly impact attitudes towards receiving care and
influence further utilization of health care services. Data from the National
Co-morbidity Study show that although African Americans had more favorable
attitudes towards seeking mental health services than whites prior to using
them the reverse was true after using them. Nearly 27% of African American
respondents to the King County Survey reported that as a result of a
discriminatory event that they were more hesitant to seek health services,
25.6% avoid the health care facility, 23.1% avoid the provider, 15.4% stopped
using specific services, 10.3% avoid the personnel involved and 7.7% use
services less frequently while only 25.6% did not change their behavior. Other
studies have found no association between perceived discrimination and
utilization of preventive health care services.

Racial/ethnic discrimination
also has the potential to influence the health of racial/ethnic minorities
through its association with changes in mental and physiologic states and
through its influence on participation in high-risk behaviors such as excessive
alcohol consumption and substance abuse. Several studies have examined the
effect of racial discrimination on mental health and, in general, show that
racial discrimination can be a significant source of stress for racial/ethnic
minority populations and is associated with decreases in the sense of
well-being including self-esteem, happiness, life satisfaction; and increased
psychosis, hopelessness, anxiety, anger and substance abuse. Perceived
discrimination has also been found to be associated with depression. Studies
that have examined the influence of self-reported experiences with
racial/ethnic bias and physiologic changes have however, provided inconsistent
results. For example, some studies have shown an association between
discrimination related stress and increases in blood pressure while others have
not. Other research suggests that the association between perceived racial
discrimination and increases in blood pressure is dependent upon coping
styles. A few studies have also shown that individuals that experience
discrimination and other sources of stress have a higher prevalence of chronic
disease behavioral risks such as cigarette smoking alcohol and substance abuse.

RESEARCH SCOPE

This FOA specifically
encourages:

Descriptive and analytical studies that examine
racial/ethnic discrimination as a risk factor for racial/ethnic disparities in
disease incidence, treatment, and outcomes;

The development of data resources including the
identification and/or development of new data collection modalities and the
evaluation of existing data collection instruments/modalities;

Development of innovative methods of measuring
racial/ethnic discriminatory behavior, perception of exposure to racial/ethnic
discrimination and novel approaches to the analysis of quantitative and
qualitative data for the purpose of describing discriminatory behavior and
exposure to racial/ethnic discrimination;

Examination of the prevalence of institutional racism
in health care delivery systems or policies and its contribution to
racial/ethnic health disparities;

The development and evaluation of interventions that
enhance cross-cultural communication and reduce discriminatory behavior, the
perception of exposure to racial/ethnic discrimination, and health-related
consequences of racial/ethnic discrimination; and

Studies that examine bias/discriminatory attitudes,
beliefs and behaviors that may influence/limit access to diagnostic
technologies and therapies for racial/ethnic minorities, particularly in areas
for which serious disparities exist such as cancer and cardiovascular disease.

Studies that examine the biological and psychosocial
pathways that link exposure to discrimination and health.

All proposed studies should be sufficiently powered
to provide adequate control for potential confounders including, but not
limited to, gender, age, income, disability, and other factors that might
explain racial/ethnic differences in study outcomes. Applicants are strongly
encouraged to submit applications that go beyond simply identifying an
association between race and an outcome as the sole measure of racial/ethnic
discrimination. Studies that measure the prevalence, causes, and effects of
racial discrimination; explanatory mechanisms that lead to discriminatory
behavior, mediating factors; and processes in health delivery systems are of
particular interest.

Studies should address at least one the following:

Employ new, novel, or innovative methods for
measuring the prevalence, cause and effects of racial/ethnic
discrimination/bias, explanatory mechanisms that lead to discriminatory
behavior or mediating factors and processes in healthcare delivery systems;

Examine the prevalence of negative perceptions/or
stereotypes that providers may have of racial/ethnic minority patients that may
influence referral and/or receipt of appropriate healthcare services;

Examine private, governmental, or public
institutional policies or practices that may negatively and disproportionately
impact racial/ethnic minority receipt of appropriate healthcare services.

NOTE: For this FOA, The
National Heart, Lung and Blood Institute (NHLBI) is only interested in
receiving applications for studies that have an intervention component.

Examples of research topics and approaches that would be
relevant areas of investigation under this FOA include, but are not limited to:

1. METHODOLOGY FOR MEASURING
RACIAL/ETHNIC DISCRIMINATION

The importance and sensitivity surrounding the topic
of racial/ethnic discrimination mandates the development and utilization of
measures that assure the accuracy of reported data including both construct and
criterion validity. Appropriate studies include those that develop and
evaluate innovative methods for measuring physician and other health care
provider bias and/or use of stereotypes with racial/ethnic minority patients,
patient exposure to racial/ethnic discrimination, and patient strategies used
to cope with exposure to racial/ethnic discrimination in health delivery
systems. With the exception of studies that examine patient perception of
exposure to discriminatory behavior, studies should go beyond simply
identifying an association between race and health outcomes as a measurement of
discrimination. Methods for assessing the influence of patient bias towards
health care providers from non-concordant racial/ethnic groups are also of
interest.

2. DISCRIMINATORY BEHAVIOR
BY PROVIDERS OR OTHER STAFF IN THE HEALTH CARE SETTING

Studies that examine factors that influence patient
experiences and perception of racial/ethnically biased health care and its
relationship to trust of health care providers and its influence on the future
utilization of health care services including compliance with provider
recommendations, delays in seeking care, and continuity in care.

Studies that examine racial/ethnic concordance,
provider communication styles and their relationship to patient perception of
the receipt of racially/ethnically biased care.

4. INSTITUTIONAL RACISM

Studies that examine the impact of health delivery
system practices and policies such as patient dumping, Medicare nursing care
bed certification limits, privatization, closure or relocation of public
hospitals, or other policies that may adversely impact the supply of racial/ethnic
minority health care providers and how this might relate to racial/ethnic
disparities in access to care, health status and outcomes.

Studies of health delivery systems, health care
policies, and changes to systems and policies that have a disparate impact on
racial/ethnic minorities and the roles that they might play in racial/ethnic
health disparities including the utilization of health services and receipt of
appropriate care by members of racial and ethnic minority populations.

Studies that focus on measurement of organizational
factors and relationships between organizational entities such as treatment
agencies and other health, social services, and criminal justice system
agencies as they relate to the disproportionate use and availability of health
care services among racial/ethnic minorities.

The role of public and institutional policies as they
relate to the disproportionate use, availability or satisfaction with health
care services among racial/ethnic minorities.

The association between racial/ethnic stigma and gaps
between health care needs (e.g. treatment, prevention, and related services)
and service availability.

The role of economic and personal costs as they
relate to the disproportionate use, availability, and satisfaction with health
care services among racial/ethnic minorities.

Studies of policy shifts (privacy policies, treatment
immediacy, cost variation) in service delivery and their affect on
racial/ethnic minority populations.

5. THE EFFECTS OF
RACIAL/ETHNIC DISCRIMINATION OR PERCEPTION OF DISCRIMINATION ON ON RECEIPT OF
HEALTH CARE SERVICES AMONG RACIAL/ETHNIC MINORITY PATIENTS

Patient beliefs systems, personal biases and
attitudes, and their impact on relationships with providers and on the
utilization of health care services and receipt of appropriate care.

Patient experiences or perceptions of
racially/ethnically biased health care and its influence on the future
utilization of health care services and willingness to comply with physician
recommendations.

The role of racial/ethnic stigma and discrimination on
the willingness to seek health care.

Studies to assess the role of culture, behaviors, and
attitudes on perceived racial and ethnic discrimination in the delivery and
access to quality care.

Stereotype threat and its relationship to health care
utilization.

6. INTERVENTION STUDIES

Studies that test interventions designed to reduce
provider bias and/or patient perception of racial/ethnic discrimination or
consequences designed to ensure the receipt of quality medical care among
racial/ethnic minority patients are of particular interest. Proposed
interventions should be based on empirical data from adequately powered
preliminary/pilot studies that support the need for and potential benefit from
the specific intervention in the proposed target population.

Studies to assess the
relationship between perceived health care discrimination and use of
intervention, prevention, and treatment services.

Section II. Award Information

Funding Instrument

Grant

Application Types Allowed

New
Resubmission
Revisions

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations,
and the submission of a sufficient number of meritorious applications.

Award Budget

Direct costs are limited to $275,000 over an R21 two-year
period, with no more than $200,000 in direct costs allowed in any single year.

Award Project Period

The total project period for an application submitted in
response to this funding opportunity may not exceed two years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions:

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Project Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission
Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and
Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant Electronically”
button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
application submission. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed.

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424
(R&R) Application Guide, with the following modifications:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

Foreign Organizations

Foreign (non-US) organizations must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign organizations described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD/PIs must include their eRA Commons ID in the Credential
fieldof the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review , NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered in
the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

The R21 exploratory/developmental grant supports investigation of novel
scientific ideas or new model systems, tools, or technologies that have the
potential for significant impact on biomedical or biobehavioral research. An
R21 grant application need not have extensive background material or
preliminary information. Accordingly, reviewers will focus their evaluation on
the conceptual framework, the level of innovation, and the potential to
significantly advance our knowledge or understanding. Appropriate justification
for the proposed work can be provided through literature citations, data from
other sources, or, when available, from investigator-generated data.
Preliminary data are not required for R21 applications; however, they may be
included if available.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers
well suited to the project? If Early Stage Investigators or New Investigators,
or in the early stages of independent careers, do they have appropriate
experience and training? If established, have they demonstrated an ongoing
record of accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not recommended for approval by the committee,
then the committee will consider whether the responses to comments from the
previous scientific review group are adequate and whether substantial changes
are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign
Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds
with all other recommended applications. Following initial peer review, recommended
applications will receive a second level of review by the appropriate national Advisory Council or Board . The following will be considered in making funding
decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention
statement, and Financial Status Report are required when an award is
relinquished when a recipient changes institutions or when an award is
terminated.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.